It may have been a coincidence that the US Food and Drug Administration (FDA) chose the day before Joe Biden’s inauguration as president to present extra guidance on the minimum requirements for the content and format of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports, but the timing seems at the very least symbolic.
The agency said it had received “thousands of premarket applications that range widely in the level of detail they contain” and so set out to provide applicants with “a better understanding” of what was required.
It was surely not coincidental that little more than a week after the run-off elections in Georgia confirmed that the Democratic Party would take control of the US Senate, 12 senators – 11 of them Democrats, including their deputy Senate leader and the new chair of the Health, Education, Labor and Pensions Committee, which has jurisdiction over the FDA – wrote to the agency urging it to crack down on all companies that did not submit a PMTA before the 9th September 2020 deadline, including “removing all unauthorized new tobacco products from the market”.
Put together, these moves suggest that life is not about to get easier for vape manufacturers under the new Democratic regime.
Ironing out the wrinkles
Watch out for a possible ironing out of inconsistencies in the detail of regulation across the nation – wrinkles that were highlighted this week by Ron Marshall, a Republican state representative in Montana, who has put forward a state bill to stop local and county governments from slapping extra rules on vapour products.
Marshall, co-owner of a small vape store chain and a member of the Montana Smoke-Free Association, said: “There’s a lot of holes, and 56 counties in Montana means 56 different sets of rules. Everything should go through the legislative body when it comes to law. It’s just one of those things where everybody needs to be on the same page, and we need to have a clear definition of what these products are.”
No one, surely, could argue with that. Marshall may not find any coming nationwide evening-out of the rules entirely to his liking, however. And while one might think the incoming administration had more pressing issues on its plate than e-cig regulation, the moves on PMTAs mentioned above suggest vapes haven’t fallen off the bottom of the agenda.
From the perspective of a Democratic Party not supposed to be on the side of big business – especially big tobacco business – there may be an irony, however.
The tougher the rules and enforcement on matters like PMTAs, the more the costs spiral beyond the means of the small independent companies that were originally at the heart of the vapour business. Potentially leaving the way clear for the big boys.
Photo: Ted Eytan